Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Phase 1

Completed

• Conditions: Acute Gastroenteritis
• Interventions: Drug: Gelatin Tannate; Drug: Placebo

• Registration Number: NCT02280759
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Study Start: 2014-11
• Primary Completion: 2017-06-10
• Study Completion: 2017-06-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• children < 5 years old
• diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
• inform consent sign

Exclusion Criteria

• regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
• underlying gastrointestinal tract disorder presenting with diarrhea
• breastfeeding >50%
• malnutrition (weight/high <3pc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelatin Tannate	Gelatin Tannate	Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.
Placebo	Placebo	Placebo consists of an identical formulation, except active substance.

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea	7 days	time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours

Secondary Outcome Measures

Name	Time	Method
Need of hospitalization in outpatients	7 days
Vomiting	How many times for 7days
Weight gain	7 days
Diarrhea recurrence	7 days
Frequency of watery stools	7 days
Adverse effects	7 days
Severity of diarrhea due to modified Vesikari score	7 days
Need of intravenous rehydration due to diarrhea	7 days

Trial Locations

Locations (1)

Department of Paediatrics, The Medical University of Warsaw, Poland; 🇵🇱 Warsaw, Poland